Wilmington – Attorney General Beau Biden today reached a settlement agreement with pharmaceutical manufacturer Pfizer that resolves allegations the company engaged in unfair and deceptive practices in promoting its drugs Zyvox and Lyrica. Biden joined 33 other State Attorneys General in the $42 million nationwide agreement. Delaware will receive $633,000, which will be paid to the Attorney General’s Consumer Protection Fund.
“Doctors and patients rely on drug manufacturers for accurate and reliable information about their products when making critical decisions about their use of life-saving medications,” Biden said. “We’re acting today and will continue to be vigilant in acting to hold pharmaceutical companies accountable for marketing their drugs only for uses that are safe and approved.”
Pfizer’s antibacterial drug Zyvox has been approved by the Food and Drug Administration for the treatment of certain types of infections, including those caused by methicillin-resistant Staphylococcus aureus, commonly referred to as “MRSA.” Biden and his fellow Attorneys General allege that Pfizer made misleading and unsubstantiated claims in marketing Zyvox as superior to the long-established antibiotic vancomycin, even though Zyvox has not been demonstrated by substantial evidence to be superior to vancomycin for certain uses as Pfizer marketed. Moreover, the Attorneys General allege that Pfizer continued to make superiority claims after it received a Warning Letter from the FDA claiming that a Pfizer advertisement misbranded Zyvox by making misleading and unsubstantiated implied superiority claims.
In addition, the Attorneys General allege that Pfizer marketed its drug Lyrica for uses that had not been approved by the FDA. Lyrica was approved by the FDA for treating diabetic peripheral neuropathy (DPN), post-herpetic peripheral neuropathy (PHN) and the adjunct treatment of partial seizures. Contrary to the FDA-approved uses, Pfizer marketed Lyrica for unapproved off-label uses, including the treatment of chronic pain, neuropathic pain (other than DPN and PHN), perioperative pain, and migraine.
As a result of today’s agreement, Pfizer will make changes to its marketing and promotion practices of Zyvox and Lyrica. Specifically, Pfizer will not:
• Make any false, misleading, or deceptive claims when comparing the efficacy or safety of Zyvox to vancomycin;
• Promote any Pfizer product for off-label uses;
• Fail to design financial incentives that ensure that its marketing personnel are not motivated to engage in the improper marketing of Zyvox or Lyrica; or
• Fail to notify its sales force promptly of any warning letter received from the FDA that affects sales representatives in the promotion of Pfizer products.
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